Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00891241 | A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure | PHASE1 | COMPLETED | 12 | — | — | Aug 1, 2009 | Nov 1, 2009 | Nov 16, 2020 | 2 | United States |
Number of study subjects exhibiting treatment-related adverse events
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Healthy Population |
| Cohort 2 | EXPERIMENTAL | Heart Failure Subjects with a documented ejection fraction of 35% or less, and a diagnosis of NYHA Class II-III heart failure, history of ventricular arrhythmia and ICD placement |
| Name | Type | Description |
|---|---|---|
| LMI 1195-101 | DRUG | Single dose, bolus IV injection of LMI 1195 |
Cohort 1 Inclusion: * Healthy, age 18-40 Cohort 1 Exclusion: * Significant or chronic medical illness * Pregnant females * Smoking within one month of enrollment * Use of any prescription drugs within 4 weeks prior to dosing Cohort 2 Inclusion: * 30-70 year old subjects with a diagnosis of NYHA...